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Recruiting NCT03042221

Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy

— Observational Non-Small Cell Carcinoma of Lung, TNM Stage 4 Non-Small Cell Lung Cancer EGFR Gene Mutation ALK Gene Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer

Overview

A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival/ resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.

Primary outcome measures

  • gene expression changes [Time frame: baseline and 2 weeks (+/- 1 week) for each patient.]
  • protein expression change [Time frame: baseline and 2 weeks (+/- 1 week) for each patient.]
Secondary outcome measures (1)
  • Depth of Response [Time frame: Study startup through 36 months]

Eligibility criteria

Inclusion criteria

Targetable Oncogene - Biopsy Cohort (includes blood draw)

  • Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
  • Aged 18 years or older
  • ECOG 0-2
  • Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
  • No prior systemic therapy for locally advanced or metastatic disease.
  • Planned treatment with targeted therapy specific to the oncogene driver mutation.
  • Patients must have at least one site of measurable disease ≥ 2cm.
  • Primary disease site or site of metastatic disease must be amenable to biopsy.
  • Patients must have the ability to understand and willingness to sign an informed consent document.

Targetable Oncogene - Blood Draw Only Cohort

  • Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)
  • Aged 18 years or older
  • ECOG 0-2
  • Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
  • No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)
  • Planned treatment with targeted therapy specific to the oncogene driver mutation.
  • Declines repeat biopsy option or does not have tumor site amenable to biopsy.
  • Patients must have the ability to understand and willingness to sign an informed consent document.

Immunotherapy Cohort - Blood Draw Only

  • Have a histologically confirmed diagnosis of locally advanced or stage IV NSCLC without a treatable activating mutation that would be amenable to targeted therapy AND planned first line treatment with immunotherapy or chemotherapy plus immunotherapy.
  • Aged 18 years or older
  • ECOG 0-2
  • No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)
  • Patients must have the ability to understand and willingness to sign an informed consent document.

Exclusion criteria

Targetable Oncogene - Biopsy Cohort (includes blood draw)

  • Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
  • Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
  • Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .

Targetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only

  • Planned follow up on therapy outside of the University of Colorado Health System
  • Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • University of Colorado, Cancer Center — Aurora

Identifiers

NCT: NCT03042221 · 15-2316.cc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗